Iowa Code 126.11 – Exemptions in cases of drugs and devices — dispensing by prescription only
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1. The board shall adopt rules exempting from any labeling or packaging requirement of this chapter drugs and devices which are, in accordance with the practice of the trade, to be processed, labeled, or repacked in substantial quantities at establishments other than those where originally processed or packaged, on condition that such drugs and devices are not adulterated or misbranded upon removal from the processing, labeling, or repacking establishment.
Terms Used In Iowa Code 126.11
- Board: means the board of pharmacy. See Iowa Code 126.2
- Device: means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory of any of these, which is any of the following:a. See Iowa Code 126.2
- Drug: means any of the following, but does not include a device:
a. See Iowa Code 126.2- Facsimile prescription: means a prescription which is transmitted by a device which sends an exact image to the receiver. See Iowa Code 126.2
- following: when used by way of reference to a chapter or other part of a statute mean the next preceding or next following chapter or other part. See Iowa Code 4.1
- Label: means a display of written, printed, or graphic matter upon the immediate container of an article; and a requirement made by or under authority of this chapter that any word, statement, or other information appear on the label is not complied with unless the word, statement, or other information also appears on the outside container or wrapper of the retail package of the article, or is easily legible through the outside container or wrapper. See Iowa Code 126.2
- Labeling: means all labels and other written, printed, or graphic matter upon an article or any of its containers or wrappers, or accompanying an article. See Iowa Code 126.2
- Rule: includes "regulation". See Iowa Code 4.1
- State: means a state, territory, or possession of the United States, the District of Columbia, or the Commonwealth of Puerto Rico. See Iowa Code 152E.3
2. Drug and device labeling or packaging exemptions adopted pursuant to the federal Act shall apply to drugs and devices in this state except insofar as modified or rejected by rules adopted by the board.3. a. (1) This paragraph “a” applies to a drug intended for use by humans which is any of the following:(a) Is a habit-forming drug to which section 126.10, subsection 1, paragraph “d” applies.(b) Because of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, is not safe for use except under the supervision of a practitioner licensed by law to administer the drug.(c) Is limited by an approved application under section 505 of the federal Act to use under the professional supervision of a practitioner licensed by law to administer the drug.(2) Such a drug shall be dispensed only upon a written, electronic, or facsimile prescription of a practitioner licensed by law to administer the drug, or upon an oral prescription of such a practitioner which is reduced promptly to writing and filed by the pharmacist, or by refilling any such written, electronic, facsimile, or oral prescription if the refilling is authorized by the prescriber either in the original written, electronic, or facsimile prescription or by oral order which is reduced promptly to writing and filed by the pharmacist. The act of dispensing a drug contrary to this paragraph “a” while the drug is held for sale results in the drug being misbranded.b. A drug dispensed by filling or refilling a written, electronic, facsimile, or oral prescription of a practitioner licensed by law to administer the drug is exempt from section 126.10, except section 126.10, subsection 1, paragraph “a”, section 126.10, subsection 1, paragraph “i”, subparagraphs (2) and (3), and section 126.10, subsection 1, paragraphs “k” and “l”, and the packaging requirements of section 126.10, subsection 1, paragraphs “g”, “h”, and “p”, if the drug bears a label containing the name and address of the dispenser, the date of the prescription or of its filling, the name of the prescriber, and, if stated in the prescription, the name of the patient, and the directions for use and cautionary statements, if any, contained in the prescription. This exemption does not apply to a drug dispensed in the course of the conduct of the business of dispensing drugs pursuant to diagnosis by mail, or to a drug dispensed in violation of paragraph “a” of this subsection.c. The board may, by rule, remove a drug subject to section 126.10, subsection 1, paragraph “d”, and section 505 of the federal Act from the requirements of paragraph “a” of this subsection when such requirements are not necessary for the protection of the public health.d. A drug which is subject to paragraph “a” of this subsection is misbranded if, at any time prior to dispensing, its label fails to bear the statement: “Caution: Federal Law Prohibits Dispensing Without Prescription”, or “Caution: State Law Prohibits Dispensing Without Prescription”. A drug to which paragraph “a” of this subsection does not apply is misbranded if, at any time prior to dispensing, its label bears the caution statement quoted in the preceding sentence.e. Prescription drug samples dispensed by a practitioner licensed by law to administer such drugs are exempt from section 126.10.f. All electronic or facsimile prescriptions transmitted under this section shall comply with section 155A.27. - Drug: means any of the following, but does not include a device: